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Lucid Diagnostics, Inc. recalls Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software
Recalled June 5, 2024 · FDA recall Z-1899-2024 · Lucid Diagnostics
Hazard
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. · FDA Class II
Units
157 units (US)
Sold at
US Nationwide distribution in the states of MN, MD.
Description
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
Product
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
Manufacturer(s)
Lucid Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →